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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
510(k) Number K210973
Device Name MammaPrint FFPE NGS Kit
Agendia Inc.
22 Morgan
Irvine,  CA  92618
Applicant Contact Marcelo Trevino
Agendia Inc.
22 Morgan
Irvine,  CA  92618
Correspondent Contact Marcelo Trevino
Regulation Number866.6040
Classification Product Code
Date Received03/31/2021
Decision Date 09/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No